Optimum Imaging Diagnostics L L C

FDA Filings

This page includes the latest FDA filings for Optimum Imaging Diagnostics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011875106
FEI Number3011875106
NameOPTIMUM IMAGING DIAGNOSTICS, LLC
Owner & OperatorOptimum Imaging Diagnostics
Contact AddressSuite 1 6 Science Park Road
Scarborough ME 04074 US
Official Correspondent
  • Paul E Hamm
  • x-207-2170659-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6 SCIENCE PARK RD STE 1
Scarborough, ME 04074 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HEA-820-10010 Synthetic Urine Negative Control2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10223 Color Developer2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10222 Stop Solution2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GPR-950-10221 Wash Buffer2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HEA-820-10076 Mid Positive Control2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
GLM-950-10045 Positive Stock Standard2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HSR-920-10044 Anti-Histoplasma Conjugate2018-10-03
OPTIMUM IMAGING DIAGNOSTICS, LLC [Optimum Imaging Diagnostics]
HSR-910-10043 - Anti-Histoplasma Coated Microwells2018-10-03

Related Finance Registrations
NCAGE Code8H5J6OPTIMUM IMAGING DIAGNOSTICS, LLC
CAGE Code8H5J6OPTIMUM IMAGING DIAGNOSTICS, LLC
S.A.M. Registration8H5J6 [80029651]OPTIMUM IMAGING DIAGNOSTICS, LLC
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